Trial Outcomes & Findings for Shifting Rehabilitation Paradigms in Skilled Nursing Facilities (NCT NCT02927171)
NCT ID: NCT02927171
Last Updated: 2020-04-03
Results Overview
Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
Results posted on
2020-04-03
Participant Flow
Participants were recruited from a skilled nursing facility between the dates of 02.28.2016 and 10.30.2018
There were no exclusions of participants. All eligible, willing participants were allocated to one of two arms.
Participant milestones
| Measure |
Usual Care
Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
|
I-STRONGER
IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
53
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Usual Care
Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
|
I-STRONGER
IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
Baseline characteristics by cohort
| Measure |
Usual Care
n=53 Participants
Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
|
I-STRONGER
n=50 Participants
IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
77.3 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
77.65 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.
Outcome measures
| Measure |
Usual Care
n=53 Participants
Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
|
I-STRONGER
n=50 Participants
IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
|
3.6 score on a scale
Standard Deviation 2.3
|
4.3 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)Time it takes to walk a 4 meter path. Lower scores indicate better function.
Outcome measures
| Measure |
Usual Care
n=53 Participants
Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
|
I-STRONGER
n=50 Participants
IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
|
|---|---|---|
|
Gait Speed
|
0.3 seconds
Standard Deviation 0.2
|
0.5 seconds
Standard Deviation 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Quantification at SNF Discharge (Expected average length of stay: 21 days)8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction.
Outcome measures
| Measure |
Usual Care
n=53 Participants
Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
|
I-STRONGER
n=50 Participants
IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.
IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
|
|---|---|---|
|
Patient Satisfaction Survey
|
54.6 score on a scale
Standard Deviation 7.9
|
59.4 score on a scale
Standard Deviation 7.3
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
I-STRONGER
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Stevens-Lapsley
University of Colorado Denver
Phone: 303.724.9170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place